Focused Review of a
Sentinel Event
Root Cause Analysis
Determination
the Need for
Focused Review
• When something goes wrong, the
appropriate clinical experts are in
consultation
–
–
–
–
–
Administration
Physician leadership
Nursing leadership
Risk Management
Quality Management
Determination
of Need for
Focused Review
continued
• It is determined that the event meets
the definition for sentinel events
– NQF 27 Adverse Event Criteria
– JCAHO Minimum Criteria
• The event is a near miss (good catch)
– the event has resulted or could have resulted
in patient harm
• Problems keep repeating
NQF Adverse
Events
• Surgical Events
• Product or Device
Events
• Patient Protection
Events
• Care Management
Events
• Environmental Events
• Criminal Events
JCAHO
Minimum
Events
• Events resulting in an unanticipated death or
major permanent loss of function, not related
to the natural course of the patient’s illness or
underlying condition
JCAHO
Minimum
Events
• Event is one of the following (even if the outcome was not
death or major permanent loss of function unrelated to the
natural course of the patient’s illness or underlying condition)
– Suicide of any individual receiving care, treatment or services in a
staffed around-the-clock care setting or within 72 hours of discharge
– Unanticipated death of a full-term infant
– Abduction of any individual receiving care, treatment or services
– Discharge of an infant to the wrong family
– Rape
– Hemolytic transfusion reaction involving administration of blood or
blood products having major blood group incompatibilities
– Surgery on the wrong individual or wrong body part
– Unintended retention of a foreign object in an individual after surgery
or other procedure
JCAHO
Minimum
Events
• Unanticipated death or major permanent loss
of function associated with a health careacquired infection
• Severe neonatal hyperbilirubinemia (bilirubin
>30 milligrams/deciliter)
• Prolonged fluoroscopy with cumulative dose
>1500 rads to a single field, or any delivery of
radiotherapy to the wrong body region or
>25% above the planned radiotherapy dose
Other events
where RCA
could be
considered
• Near Misses
• Repeated problems
• Events which have resulted in
patient harm, or could have resulted
in patient harm
– “Risk thereof”
Safety
Assessment
Code
• Assists to prioritize safety related
problems
• Applies resources (time) where they
have the greatest opportunity to improve
safety
• A tool intended to prioritize safety
events yet not take the place of judgment
• Based on 2 dimensions
Safety
Assessment
Code
Severity:
• Based on actual and potential risk – “worst
case”
• Needs to have consistent definition
• Should be determined first
Safety
Assessment
Code
• Catastrophic
– Death or major permanent loss of function not related to
natural course of illness or underlying condition
• Major
– Permanent lessening of bodily function not related to
natural course of illness or underlying condition
• Moderate
– Increased length of stay or level of care
• Minor
– No injury, no increased length of stay or level of care
Safety
Assessment
Code
Probability:
• More subjective, greater chance of variation
• Should be reflective of the facility
• Categories
–
–
–
–
Frequent
Occasional
Uncommon
Remote
Safety Assessment Matrix
Frequency
SEVERITY
Catastrophic
Major
Moderate
Minor
Frequent
3
3
2
1
Occasional
3
2
1
1
Uncommon
3
2
1
1
Remote
3
2
1
1
Adapted from:
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1695
Sentinel Event
Focused Review
Algorithm
It is determined
that a focused
review should be
conducted
Manager schedules
the RCA to be
conducted within
30 days of the event
Measurement plan
is implemented;
the action plan is
evaluated for
effectiveness
RCA documents
are reviewed by
medical staff in the
Department Meeting
(includes action plan)
The RCA is
conducted and an
action plan is
established
The action plan is
facilitated by the
manager
Root Cause
Analysis
• Participating in a RCA is an
opportunity to learn
• Opportunity for staff to tell their
story
• Emphasis is on improving the
system and not correcting the
individuals
Root Cause
Analysis
• Systematic process for identifying the
most basic causal factor or factors for
an undesirable event or problem
• Focus is on process and systems, not
individuals
• Frequently ask “why “
• Confidential
• Conduct within 45 days
Root Cause
Analysis
• Who
• What
• When
• Where
• Why
Goals of a
Root Cause
Analysis
• Mechanism for reporting
Sentinel Events
• Investigating and evaluating
causative factors
• Initiation of performance
improvement
• Action plan development to
prevent recurrence
Goals of a
Root Cause
Analysis
Understand the sequence of events
– Flow chart
– Cause and Effect Diagram
Chronological details can be done before to
save time
Reviewing literature can help the team to
differentiate between what they may or may
not have within their control
RCA Team
• Multidisciplinary :
– Key staff and departments directly
and indirectly involved in the event
– Physicians, nurses and managers
– Performance Improvement Staff
Key Aspects
• CONFIDENTIAL
• Safe protected environment
• Quality Management v.s. Risk
Management
• Gain better insight into processes
involved in the event
– Frequently asks “why”
• Peer Review
– MN Statute §§ 145.61
• QM acts as a facilitator
Key Elements
of RCA
•
•
•
•
•
•
•
•
•
Details of the event
Human factors
Staffing
Communication
Education
Equipment
Environmental
Uncontrollable external factors
Other factors
Triage
Questions
• Helps team understand event
• Assures thoroughness of
investigation
– Human factors/Communication
– Human factors/Training
– Human factors
fatigue/scheduling
– Environment/Equipment
– Rules/Policies/Procedures
– Barriers
Minimum Scope of Root Cause Analysis for Specific Types of Sentinel
Events
Detailed inquiry into these areas is expected when conducting a root cause analysis for the
specified type of sentinel event
Inquiry into areas not checked (or listed) should be conducted as appropriate to the specific event
under review.
Suicide
(24care)
Med
Error
Procedure
Complic
Behavioral assessment
process*
Physical assessment
process**
Patient identification
process
Patient observation
process
Care planning process
X
Staffing levels
X
X
X
Orientation & training of
staff
Competency assessment/
credentialing
Supervision of staff***
X
X
X
Communication with
patient/family
Communication among
staff members
Availability of
information
Adequacy of
technological support
Equipment maintenance/
management
Physical environment****
X
Security systems and
processes
Control of medications:
storage/access
Labeling of medications
X
X
Wrong site
surgery
Treatment
delay
X
X
Restraint
death
Elopement
death
Assault,
rape,hom
X
X
X
X
X
X
Transfusin
death
Infant
abduction
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
RCA Reporting
Tools
• Root Cause Analysis
Summary
• Root Cause Analysis
Corrective Action Plan
• Confidential under MN
Statute §§ 145.61
Root Cause
Analysis
Summary
To be thorough, a RCA must
include:
– Determination of human and
other factors
– Determine related processes
and systems
– Analysis of underlying causes
and effects – series of why’s
– Identification of risks and their
potential contributions
Determining
the
Root Cause
• 5 Rules of Causation
– Causal statements must clearly
show the “cause and effect”
relationship
– Negative descriptors are not used in
a causal statement
– Each human error must have a
preceding cause
– Each procedural deviation must
have a preceding cause
– Failure to act is only causal when
there was a pre-existing duty to act
HealthEast Root Cause Analysis Summary
Level of Analysis
Questions/Factors
involved
What happened:
What departments were
involved?
What are the details of the
event?
Why did it happen:
What was the missing or weak
(Proximate cause)
step in the process?
Why did that happen?
What caused the missing or
weak step in the process?
Why did that happen? What is currently done to
prevent failure at this step?
Why did it happen:
What was the human error?
(Proximate cause)
Why did that happen?
Was staff performance in the
process addressed?
Was staff properly qualified?
Was staffing adequate?
Why did that happen? Can orientation and inservice
training be improved?
Why did it happen:
Was all necessary information
available:
-when needed?
-accurate?
-complete?
Why did that happen?
Is communication among
participants adequate?
Why did that happen? Are there barriers to
communication?
Is prevention of adverse
outcomes considered a high
priority?
(Proximate cause)
Findings and Opportunities to Improve
Why did it happen:
How did the equipment fail?
What broke?
Why did that happen?
What is currently being done to
prevent an equipment failure?
Why did that happen? What is currently being done to
protect against a bad outcome if
an equipment failure does
occur?
(Proximate cause)
Why did it happen:
What environmental factors
directly affected the outcome?
Why did that happen?
Was the physical environment
appropriate for the process to be
carried out?
Why did that happen? Are systems in place to identify
environmental risks?
Are responses to environmental
risks planned and tested?
(Proximate cause)
Why did it happen:
Were there any uncontrollable
external factors?
Why did that happen?
Are they truly beyond the
organization’s control?
Why did that happen? How can we protect against
them?
(Proximate cause)
Why did it happen:
Were there any other factors that
directly influenced the outcome?
Why did that happen?
What caused the breakdown at
this step in the process?
Why did that happen? How can we protect against
them?
(Proximate cause)
Type of Event:












Patient suicide
Op/post-op complication
Medication error
Wrong-site surgery
Delay in treatment
Patient death/injury in restraints
Patient fall
Assault/rape/homicide
Patient elopement
Perinatal death/loss of function
Transfusion error
Fire












Infant abduction/wrong family
Medical equipment – related
Ventilator death/injury
Maternal death
Death associated with transfer
Utility system failure
Anesthesia – related
Infection – related
Dialysis – related
In-patient drug overdose
Self-inflicted injury
Other (less frequent)









Communication with patient/family
Communication among care team members
Availability of information
Adequacy of technological support
Equipment maintenance/management
Physical environment
Security systems and processes
Control of medications: storage/access
Labeling of medications
Root Cause(s) Identified by the RCA Team:
Check categories that apply:
 Behavioral assessment process
 Physical assessment process
 Patient identification process
 Patient observation procedures
 Care planning process/coordination of care
 Staffing levels
 Orientation and training of staff
 Competency assessment/credentialing
 Supervision of staff
 Access to care
Additional Details:
Patient Name/Number:
Where incident occurred:
Date of incident:
Date Root Cause Analysis Completed:
Participants in Root Cause Analysis:
Conclusions/Recommendations:
Please list references of literature search:
Please attach the associated policies:
(articles can be found in the central library)
(including any newly revised policies)
See attached bibliography.
Questions?
Focused Review of a
Sentinel Event
Developing a Corrective
Action Plan
Corrective
Action Plan
• Historically the weakest link to the process
• Often RCA teams conclude solutions based
on:
– Recognition of warning signs
– Training/education
– Asking clinicians to “be more careful”
• Creates challenges for the RCA team
Corrective
Action Plan
• Strong actions:
– Physical plant changes
– New device with usability testing prior to
purchase
– Forcing functions
– Simplifying process – remove unnecessary steps
– Standardize process/equipment
– Leadership is actively involved
Corrective
Action Plan
• Intermediate actions:
–
–
–
–
–
–
–
–
Decrease workload
Software enhancements/modifications
Eliminate/reduce distraction
Checklists/cognitive aids/triggers/prompts
Eliminate look alike and sound alike
Read back
Enhanced documentation/communication
redundancy
Corrective
Action Plan
• Weak actions:
–
–
–
–
–
Double checks
Warnings/labels
New policies/procedures/memorandums
Training/education
Additional study
Corrective
Action Plan
• Do the Actions meet the following:
– Address the root cause and contributing
factors
– Specific
– Easily understood and implemented
– Developed by process owners
– Measurable
Corrective
Action Plan
• Identifies opportunities
for improvement
• Assigns responsibility
for actions
• Target dates are set for
completion
• Looks at follow up for
effectiveness by using a
measurement plan
Measure of
Effectiveness
Why Measure?
• Confirmation that what we wanted to
accomplish did in fact occur
• Measures effectiveness of action, not the
completion of the action
• “All improvement will require change, but
not all change will result in improvement”
G. Langley, et al
• “In God we trust. All other bring data”
W.E Deming
How will we know that the change
results in improvement?
Measurement answers the question
• Quality improvement measurement is for learning,
not judgment, not research
• All measures have limitations
• Measurement should be used to guide improvement
and test changes
• Focus on the changes made in the action plans
What to Measure
Outcome Measures
• Reflect cumulative impact of
multiple processes
• “Big picture”
– Are we doing the right thing
– Are we getting the results we
want
– Did we influence the health of
the patient
• Reflect the health state of a
patient resulting from our care
• Further investigation is needed
to understand what processes
need to be changed
Outcome Measures
• How many falls on this
unit?
• How many pressure ulcers
occurred on this unit?
• How many wrong site
surgery events did we
have?
• How many medication
errors occurred on this
unit
What to Measure
Process Measures
Reflect current condition of our
processes
– Are they still working for us
– Are we using them
– Are we using the accurately
• Determine if processes are
functioning effectively and
efficiently
• Used to assess adherence to
recommendations in clinical
practice
• Able to identify specific areas
of care that may require
improvement
Process Measures
• How many patients had the
tool to assess for risk of falls
• How many patients with a
Braden score of 6 had a
WOC nurse consult
• How many times was the
pause for cause observed
correctly
• How many nurses matched
the patient’s ID band to the
MAR
How to Measure
Complex and untimely
Guide change, indicate
progress, timely
• Chart abstraction
• Financial reports
• Data obtained from
existing databases and
systems
•
•
•
•
•
•
Tally sheets
Checklists
Questionnaires
Feedback interviews
Observation
Daily reviews
Measure of
Effectiveness
Measurement Plan
• Measures effectiveness of action, not
the completion of the action
• Defined numerator/denominator
• Defined sampling plan and time
frame
• Realistic performance threshold
• Plan for when initial measure did not
meet threshold
Measure of
Effectiveness
Measurement Plan Examples
• % patients with risk assessment tool
used – Randomly sample 10 patients/month for 3
months. If goal of 90% not reached, discuss with
staff to determine barriers and make necessary
changes, then re-audit.
• % Pause for Cause observed to be
correctly done by OR staff – Randomly
observe 10 surgeries/month for 3 months. If goal of
90% not reached, discuss with staff to determine
barriers and make necessary changes, then reaudit.
Spread the
Success/knowledge
• Share with staff and
Administration
– Need to go beyond “share at
staff meeting” - action is not
sustained
• Collaborate with other
units and sites
• Report sent to Medical
Department for
review/comments
CONFIDENTIAL
HealthEast
Root Cause Analysis
Protected under
Minnesota Statute §§ 145.61 et seq.
IMPROVEMENT ACTION PLAN
Type of Event:
Category of Root Cause:
Opportunity to Improve
Measures:
Follow-up for Effectiveness:
Action
Responsible
Person
Target Date For
Implementation
Completion
Date
ACTION PLAN OWNER(s):
HealthEast
Root Cause Analysis
IMPROVEMENT ACTION PLAN
Opportunity to Improve
Measures
Follow-up for Effectiveness
Action
Rating
Action
Responsible
Person
Target Date
For
Implementati
on
Completi
on
Date
Initials
Questions?
Thank You!
Rosemary Emmons RN,BSN
HealthEast Quality Management
651-232-3392 phone
651-864-2535 pager
651-232-4435 fax
remmons@healtheast.org